Systems and methods for suture delivery

ABSTRACT

Systems and methods are provided for suturing tissue. An elongated deployment shaft carries a needle deployment assembly with needles carrying suture material. A needle catcher is disposed over the shaft and configured to engage and retain at least a portion of each of the needles carrying the suture material when the needles are passed through the tissue to be sutured to a proximal position.

RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalPatent Application Ser. No. 62/006,709, filed Jun. 2, 2014 and is acontinuation-in-part application of U.S. application Ser. No.14/186,246, filed Feb. 14, 2014, the contents all of which isincorporated in its entirety herein by reference.

FIELD OF THE PRESENT DISCLOSURE

The present disclosure relates generally to techniques and devices forclosing openings in a patient's vasculature or other body lumens. Forexample, the present disclosure relates to systems, devices, and methodsfor suturing of arterial and venous puncture sites to approximate tissuearound the opening, such as may be required following a surgicalprocedure.

BACKGROUND

To improve recovery time, a variety of interventional and diagnosticprocedures may be carried out in a minimally invasive manner byaccessing a desired location within a patient's body. By introducingcatheters or other elongated devices into the vasculature at aconvenient entry point, such procedures may be performed at a remotelocation by guiding the device through the body lumen to the desiredposition. Although these techniques represent less impact on the patientthan conventional open procedures, access to the vasculature requiresforming an opening in an artery or vein that subsequently must berepaired.

A variety of methods may be used to close the access opening.Conventionally, hemostasis may be achieved through manual compression tosubstantially reduce the flow of blood through the opening and allowclot formation. Although generally successful, compression may be take asignificant amount of time and may be associated with considerablepatient discomfort. Additionally, complications such as unintended totalocclusion of the lumen that may result in ischemia or thrombosis canoccur. These aspects may be exacerbated depending upon the size of theopening necessary to introduce the device, whether anticoagulants areemployed and on the condition of the patient.

To ameliorate these problems, techniques for suturing the opening toachieve hemostasis and reduce time to ambulation have been developed. Inorder to maintain the minimal invasiveness of the procedure, many ofthese techniques are adapted to be performed. For example, the suturedelivering device may be introduced through the same opening used toperform the procedure. Typically, one or more needles are deployed bythe suture delivering device to pierce the vessel wall and draw thesuture material through so that the suture may be secured over theadventitial surface and close the opening.

Despite the benefits associated with the use of suture deliveringdevices, a number of challenges exist. In particular, it is desirablefor the needle or needles to be positioned accurately with respect tothe vessel wall so as to pierce the tissue far enough away from theopening to result in a sufficiently robust location for the suture. Itis also desirable to provide a device configured to deploy and actuatethe needles in a reproducible manner to minimize the amount of skillrequired from the operator. Accordingly, this disclosure is directed tosystems and methods for suturing an opening in a body lumen whileproviding these and other desired characteristics.

SUMMARY

This disclosure includes a suture delivery device for suturing tissue.The suture delivery device may include an elongated deployment shaft, aneedle deployment assembly carried by the shaft, including a pluralityof needles carrying suture material configured to have an insertionprofile at a distal position and to deflect radially outwards to apiercing angle when moved proximally relative to the shaft, a stabilizercarried by the shaft at a location proximal of the needle deploymentassembly, wherein the stabilizer is reconfigurable between an unexpandedinsertion profile and an expanded profile, a catcher tube coaxially andslidably disposed over the shaft having a catcher at a distal end,wherein the catcher is configured to retain at least a portion of eachof the plurality of needles carrying the suture material when theneedles are passed through the tissue to be sutured to a proximalposition that engages the catcher and a sheath coaxially and slidablydisposed over the catcher tube, wherein a distal end of the sheath isconfigured to sandwich tissue to be sutured against the stabilizer whenexpanded.

In one aspect, the device may have a handle with an actuator to expandthe stabilizer. The first actuator may also move the sheath distallyrelative to the shaft. The first actuator may be a slider moveable froma proximal position to a distal position. The slider may be coupled toproximal ends of the sheath and the catcher tube and a proximal end ofthe stabilizer may be secured to the catcher tube and a distal end ofthe stabilizer may be secured to the shaft such that movement of theslider from the proximal position to the distal position moves thecatcher tube distally relative to the shaft to decrease a distancebetween the proximal end of the stabilizer and the distal end of thestabilizer to expand the stabilizer and moves the sheath distallyrelative to the shaft to sandwich tissue to be sutured between thedistal end of the sheath and the expanded stabilizer. Further, thehandle may have a stabilizer control to automatically engage when theslider is in the distal position to prevent further relative movementbetween the catcher tube and the shaft and to prevent further relativemovement between the sheath and the shaft. Still further, the handle mayhave a release trigger to disengage the stabilizer control when theslider is in the distal position and allow further relative movementbetween the catcher tube and the shaft so that the stabilizer can returnto the unexpanded insertion profile.

In one aspect, the stabilizer may have at least one deflectable wingsthat deflect outwards when a distance between a proximal end of thestabilizer and a distal end of the stabilizer is reduced. Thedeflectable wings may have an asymmetric configuration when expandedconfigured to compensate for an insertion angle of the suture deliverydevice relative to the tissue to be sutured.

In one aspect, the device may have a handle at a proximal end of theshaft with a second actuator to move the needles proximally and distallyrelative to the shaft. The second actuator has a first range of travelto move the plurality of needles from the distal position to theproximal position. The second actuator may also have a second range oftravel to move a portion of each of the plurality of needles notretained by the catcher from the proximal position to the distalposition. The second actuator may be a plunger coupled to a plungerrack, and the device may also include a trigger rack and a pinion,wherein the plurality of needles are coupled to the trigger rack by atrigger wire slidably and coaxially disposed within the shaft, such thatduring the first range of travel, the trigger rack and the plunger rackengage the pinion so that distal movement of the plunger rack causesproximal movement of the trigger wire relative to the shaft. Further,during the second range of travel, the plunger rack may not engage thepinion and directly engage the trigger rack so that distal movement ofthe plunger rack causes distal movement of the trigger wire relative tothe shaft.

The device may also include both first and second actuators. In anembodiment, movement of the second actuator to an end of the secondrange of travel may disengage the stabilizer control to allow furtherrelative movement between the catcher tube and the shaft so that thestabilizer can return to the unexpanded insertion profile.

In one aspect, each of the plurality of needles may include a needlebase and a detachable needle tip that carries the suture material. Eachneedle tip may engage the catcher when the plurality of needles aremoved to the proximal position and the catcher may retain each needletip when each of the needle bases are returned to the distal position.Each needle base and corresponding needle tip may have a retention forceto keep the needle tips in position on the needle bases until movedproximally into engagement with the catcher. The retention force maydepend at least in part on a surface treatment, which may be a layer ofnitinol oxide.

This disclosure may also include a suture delivery device for suturingtissue having a single actuator. For example the suture delivery devicemay have an elongated deployment shaft, a needle deployment assemblycarried by the shaft, including a plurality of needles carrying suturematerial configured to have an insertion profile at a distal positionand to deflect radially outwards to a piercing angle when movedproximally relative to the shaft and a catcher tube coaxially andslidably disposed over the shaft having a catcher at a distal end,wherein the catcher is configured to retain at least a portion of eachof the plurality of needles carrying the suture material when theneedles are passed through the tissue to be sutured to a proximalposition that engages the catcher. A handle at a proximal end of theshaft may have an actuator configured to move the needles proximally anddistally relative to the shaft.

This disclosure also includes methods for delivering a suture. Forexample, a suitable method may include providing an elongated deploymentshaft, a needle deployment assembly carried by the shaft, including aplurality of needles carrying suture material, a stabilizer carried bythe shaft at a location proximal of the needle deployment assembly, acatcher tube coaxially and slidably disposed over the shaft having acatcher at a distal end, and a sheath coaxially and slidably disposedover the catcher tube, advancing the elongated deployment shaft to adesired position in a patient, reconfiguring the stabilizer from anunexpanded insertion profile to an expanded profile, sandwiching tissueto be sutured between a distal end of the sheath and the expandedstabilizer, deflecting the plurality of needles radially outwards to apiercing angle from an insertion profile at a distal position withproximal movement relative to the shaft, engaging the catcher with theplurality of needles when moved to a proximal position by passingthrough the tissue to be sutured, retaining at least a portion of eachof the plurality of needles carrying the suture material with thecatcher and returning a portion of each of the plurality of needles notretained by the catcher to the insertion profile at the distal position.

In one aspect, reconfiguring the stabilizer and sandwiching the tissueto be sutured may be performed by operating a first actuator. A proximalend of the stabilizer may be secured to the catcher tube and a distalend of the stabilizer may be secured to the shaft, so that operating thefirst actuator moves the catcher tube distally relative to the shaft todecrease a distance between the proximal end of the stabilizer and thedistal end of the stabilizer to expand the stabilizer and moves thesheath distally relative to the shaft.

In one aspect, deflecting the plurality of needles radially outward,engaging the catcher with the plurality of needles and returning aportion of each of the plurality of needles not retained by the catcherto the distal position may be performed by operating a second actuator.Operating the second actuator may include moving the second actuatorthrough a first range of travel to move the plurality of needles fromthe distal position to the proximal position and moving the secondactuator through a second range of travel to move a portion of each ofthe plurality of needles not retained by the catcher from the proximalposition to the distal position.

In yet another aspect, the disclosure includes a method for delivering asuture by providing an elongated deployment shaft, a needle deploymentassembly carried by the shaft, including a plurality of needles carryingsuture material and a catcher tube coaxially and slidably disposed overthe shaft having a catcher at a distal end, advancing the elongateddeployment shaft to a desired position in a patient, deflecting theplurality of needles radially outwards to a piercing angle from aninsertion profile at a distal position with proximal movement relativeto the shaft, engaging the catcher with the plurality of needles whenmoved to a proximal position by passing through the tissue to besutured, retaining at least a portion of each of the plurality ofneedles carrying the suture material with the catcher and returning aportion of each of the plurality of needles not retained by the catcherto the insertion profile at the distal position.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages will become apparent from the followingand more particular description of the preferred embodiments of thedisclosure, as illustrated in the accompanying drawings, and in whichlike referenced characters generally refer to the same parts or elementsthroughout the views, and in which:

FIG. 1 depicts a flowchart representing a suitable routine for deliverysutures, according to one embodiment;

FIG. 2 schematically depicts an overview of a suture delivery device ofFIG. 1, according to one embodiment;

FIG. 3 schematically depicts a detail view of a needle deploymentassembly and stabilizer of a suture delivery device, according to oneembodiment;

FIG. 4 schematically depicts a needle tips and needle bases, accordingto one embodiment;

FIG. 5-8 schematically depict engagement of needle tips with a catcher,according to one embodiment;

FIG. 9 schematically depicts engagement of needle tips with a catcherdish, according to one embodiment;

FIG. 10 schematically depicts deflection of needles to a piercing angle,according to one embodiment;

FIG. 11 schematically depicts the sandwiching of tissue to be suturedbetween an expanded stabilizer and a sheath, according to oneembodiment;

FIG. 12 schematically depicts a first embodiment of a stabilizer,according to the disclosure;

FIG. 13 schematically depicts the stabilizer embodiment of FIG. 12 inrelation to a patient's vessel wall;

FIG. 14 schematically depicts a second embodiment of a stabilizer,according to the disclosure;

FIG. 15 schematically depicts the stabilizer embodiment of FIG. 14 inrelation to a patient's vessel wall;

FIG. 16 schematically depicts a third embodiment of a stabilizer,according to the disclosure;

FIG. 17 schematically depicts the stabilizer embodiment of FIG. 16 inrelation to a patient's vessel wall;

FIG. 18 schematically depicts a fourth embodiment of a stabilizer,according to the disclosure;

FIG. 19 schematically depicts the stabilizer embodiment of FIG. 18 inrelation to a patient's vessel wall;

FIG. 20 schematically depicts a proximal position of a first actuator,according to one embodiment;

FIG. 21 schematically depicts an intermediate position of a firstactuator, according to one embodiment;

FIG. 22 schematically depicts a distal position of a first actuator,according to one embodiment;

FIG. 23 schematically depicts a proximal position of a second actuator,according to one embodiment;

FIG. 24 schematically depicts an intermediate position of a secondactuator with the pinion disengaged from the plunger rack, according toone embodiment;

FIG. 25 schematically depicts an intermediate position of a secondactuator with the plunger rack engaged with the trigger rack, accordingto one embodiment;

FIG. 26 schematically depicts another view of a second actuator,according to one embodiment;

FIG. 27 schematically depicts another view of a second actuator at anend of the second range of travel to disengage the stabilizer controland allow further relative movement between the catcher tube and theshaft so that the stabilizer can return to the unexpanded insertionprofile, according to one embodiment;

FIG. 28 schematically depicts retention of needle tips by a catcher withsuture material passed through sandwiched tissue, according to oneembodiment;

FIG. 29 schematically depicts storage of suture material within a handleof the device, according to one embodiment;

FIG. 30 schematically depicts a suture delivery device having a singleactuator, according to one embodiment;

FIG. 31 schematically depicts a detail view of the needle deploymentassembly of FIG. 30, according to one embodiment; and

DETAILED DESCRIPTION

At the outset, it is to be understood that this disclosure is notlimited to particularly exemplified materials, architectures, routines,methods or structures as such may vary. Thus, although a number of suchoptions, similar or equivalent to those described herein, can be used inthe practice or embodiments of this disclosure, the preferred materialsand methods are described herein.

It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments of this disclosure only andis not intended to be limiting.

The detailed description set forth below in connection with the appendeddrawings is intended as a description of exemplary embodiments of thepresent disclosure and is not intended to represent the only exemplaryembodiments in which the present disclosure can be practiced. The term“exemplary” used throughout this description means “serving as anexample, instance, or illustration,” and should not necessarily beconstrued as preferred or advantageous over other exemplary embodiments.The detailed description includes specific details for the purpose ofproviding a thorough understanding of the exemplary embodiments of thespecification. It will be apparent to those skilled in the art that theexemplary embodiments of the specification may be practiced withoutthese specific details. In some instances, well known structures anddevices are shown in block diagram form in order to avoid obscuring thenovelty of the exemplary embodiments presented herein.

For purposes of convenience and clarity only, directional terms, such astop, bottom, left, right, up, down, over, above, below, beneath, rear,back, and front, may be used with respect to the accompanying drawings.These and similar directional terms should not be construed to limit thescope of the disclosure in any manner.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one having ordinaryskill in the art to which the disclosure pertains. For example, the term“suturing” includes drawing two surfaces or edges together with aflexible material to close a puncture, opening, or other wound, whereinthe suture is a material that may be synthetic or natural, such as apolymer, gut, metallic wire or other suitable equivalents.

Finally, as used in this specification and the appended claims, thesingular forms “a, “an” and “the” include plural referents unless thecontent clearly dictates otherwise.

According to this disclosure, a device for applying sutures to promotehemostasis following an interventional procedure may be configured toperform a sequence of operations associated with positioning the devicein the patient's vasculature, sandwiching tissue using an expandedportion of the device to stabilize the tissue for suture deployment,deploying needles carrying suture material at a piercing angle to passthem through the stabilized tissue and returning the device to anunexpanded condition to release the sandwiched tissue and allow thedevice to be withdrawn. In particular, as will be described below,aspects of this disclosure details techniques for automating at leastsome of these operations using actuators that cause the device toperform the operations in a reproducible manner. For example, a firstactuator may be employed to expand the a distal portion of the deviceand sandwich the tissue and a second actuator may be used to deployneedles carrying suture material at a piercing angle and drive themthrough the sandwiched tissue, to capture the penetrating ends of theneedles and to return the distal portion of the device to its unexpandedcondition.

Turning now to FIG. 1, an example routine for deploying sutures using adevice of this disclosure may therefor include generally begin with 100to position the device at a desired location, such as by using a bleedback lumen with a port in the distal end of the device so that when theport is located within the vessel, blood will enter the port, flowthrough the lumen and provide a visual indication at the proximalportion of the device. Following positioning, in 102 soft tissue at thedesired suture site is stabilized by expanding a stabilizer on a distalportion of the device and sandwiching the tissue between the stabilizerand a portion of the device that is relatively more proximal. The distalexpandable stabilizer exhibits a reduced insertion profile and anexpanded profile for stabilizing tissue during delivery of the sutures.Relative movement of the stabilizer may allow tissue to be securedbetween the stabilizer and the relatively more proximal portion andprovide a target for needle-deployed sutures carried by the device. Aswill be appreciated from the discussions below, the relative movementmay involve movement of the stabilizer towards the proximal portion,movement of the proximal portion towards the stabilizer, or both. Thesandwiched tissue may include portions of the vessel wall surroundingthe puncture being closed.

Next, in 104, a plurality of needles carrying suture material that aredisposed distal of the sandwiched tissue are deployed at a piercingangle so that proximal movement of the needles in 106 penetrates thesandwiched tissue. Following penetration of the sandwiched tissue by theneedles, at least a portion of the needles are captured proximally in108. In some embodiments, this may include capturing detachable needletips that carry the suture material as will be described below. Toprepare for withdrawal of the device, in 110 the stabilizer and needledeployment mechanism are returned to their delivery configuration.According to the techniques of this disclosure, it may be desirable toautomate some or all of these operations. For example, in an embodiment,a first actuator may be used to perform 102 and a second actuator may beused to perform 104-110. Any suitable actuator configuration, includinga push button, slide slider, pull lever and/or push plunger may beemployed. Any desired number and sequence of operations may becoordinated and/or automated by linking the operations to a singleactuator.

To help illustrate aspects of this disclosure, FIG. 2 is a schematicoverview of a suture delivering device 200 according to one embodiment.Device 200 includes handle 202 having a first actuator configured asslider 204 and a second actuator configured as plunger 206. Theelongated distal portion of device 200 includes catheter 208 fordeployment within a patient's vessel. Guidewire exchange port 210 may beused to facilitate advancement of catheter 208 over a guidewire alreadypositioned within the patient's vasculature using known techniques.Proximal to catheter 208 is needle deployment assembly 212 andstabilizer 214. Stabilizer 214 may be reconfigured between the reducedprofile shown for insertion and an expanded configuration. While in itsexpanded configuration, relative movement between the distal end ofsheath 216 and stabilizer 214 may be used to sandwich tissue inpreparation of suture delivery. In this embodiment, slider 204 may beactuated to expand stabilizer 214 and generate the relative movementbetween sheath 216 and stabilizer 214. Further, plunger 206 may beactuated so that the plurality of needles within needle deploymentassembly 212 are first lifted from their insertion profile to a piercingangle and then driven to penetrate the tissue sandwiched betweenstabilizer 214 and sheath 216. Continued actuation of plunger 206 maycause at least a portion of the needles to be captured within sheath216. Subsequently, stabilizer 214 and needle deployment assembly 212 arereturned to their insertion profile to facilitate withdrawal of device200. As shown, device 200 may include a bleed back indicator 218 onhandle 202 which is in communication with a port positioned adjacentstabilizer 214 to provide visual feedback in the form of blood flow whenstabilizer 214 is positioned within the patient's vessel. Additionally,device 200 may include release trigger 220 to return stabilizer 214 toits insertion profile without actuating plunger 206 and performing theassociated operations if it becomes desirable to abort the procedurewithout deploying the needles and suture material.

In one embodiment, device 200 may include a catheter hemostasis valveproximal of guidewire exchange port 210. The valve may be positionedwithin catheter 208 and may include one or more flexible valves with anextending body to form a lumen between the valve and guidewire exchangeport 210 to facilitate introduction of a guidewire with a ramp to easethe transition to the lumen. A stopper on the valve may help secure thevalve within catheter 208, such as by using adhesives, crimping ring,friction or any other suitable methods. The flexible valve(s) may beconfigured to allow the guidewire to pass through and to block bloodflow when the guidewire is withdrawn.

Further details regarding this embodiment are depicted in FIG. 3, whichschematically shows needle deployment assembly 212 and stabilizer 214.Needle deployment assembly 212 includes a plurality of needle bases 222projecting proximally from needle pushing element 224, which may beimplemented as a piston or other suitable structure, with each needlehaving a detachable needle tip 226. Suture material may be threadedthrough or otherwise secured to an aperture in needle tip 226 (not shownin the figure for the sake of clarity). Trigger wire 228 is secured topiston 224 and extends proximally to handle 202 for actuation by plunger206 as described in further detail below. For delivery, needle bases 222and tips 226 are positioned distally of corresponding ramps 230 formedat the distal end of shaft 232. Trigger wire 228 is slidably disposedcoaxially within shaft 232 so that relative proximal movement of triggerwire 228 causes needle bases 222 and tips 226 to be deflected radiallyoutward to a piercing angle by ramps 230. Stabilizer 214 is formed byproximal band 234 and distal band 236 that are joined by at least onedeflectable wing 238. Proximal band 234 is secured to catcher tube 242,which is coaxially disposed and slidable over shaft 232. In turn,catcher 240 is coaxially disposed and slidable within sheath 216.Correspondingly, distal band 236 is secured to shaft 232. By movingcatcher 240 distally relative to shaft 232, the distance betweenproximal band 234 and distal band 236 may be decreased, causingdeflectable wings 238 to project radially outwards to expand stabilizer214 from its insertion profile.

Details regarding needle assembly 212 are shown in FIG. 4, whichschematically depicts the interaction between needle bases 222 andneedle tips 226. As shown, each needle base 222 may include post 246configured to fit within recess 248 of needle tip 226. It may bedesirable to position needle tips 226 at a specific rotationalorientation with respect to needle bases 222. In one aspect, anasymmetric configuration of post 246 and corresponding recess 248 maysecure needle tips 226 at the desired rotational orientation. Forexample, ribs or other similar features on post 246 may mate withcomplementary features of recess 248. Other means of securing needle tip226 to needle base 222 may be employed as desired, such as using a poston the needle tip and a recess in the base. Suture material 250 may beretained in aperture 227 of needle tip 226 using any suitable method,such as crimping, heating, knotting or using adhesives or plug. Asnoted, needle tips 226 may be detachable from needle bases 222. Avariety of techniques may be employed to achieve a desired degree ofretention between needle tip 226 and base 222. For example, needle tip226 may be crimped prior to or after placement on post 246 or some otherform of structural interaction may be created. In other embodiments,adhesive may be used or recess 248 may be sized somewhat smaller thanpost 246 and needle tip 226 may have a split, allowing the elasticity ofthe tip material to retain it in position. The surface quality andcoating of post 246 may also influence the retention of needle tip 226.For example, one or both of needle base 222 and needle tip 226 may beformed from a nickel-titanium alloy such as Nitinol® having superelastic and shape memory characteristics. In one aspect, either or bothof needle base 222 and needle tip 226 may have a layer of nitinol oxideto have a proper retention. Although embodiments are discussed in thecontext of four needles, any suitable number of needles may be employedas desired.

As noted, suture delivery with needle deployment assembly 212 mayinvolve an outward radial deflection of the needles to a piercing angleconfigured to penetrate the sandwiched tissue from a distal to proximaldirection, followed by the capture of at least a portion of the needles,such as needle tips 226 carrying suture material 250. Details regardingaspects of these operations are schematically illustrated in thesequence of FIGS. 5-8. Beginning with FIG. 5, needle tips 226 and needlebases 222 exhibit a reduced profile for insertion by conforming to shaft232, such as by lying in recesses. Next, FIG. 6 shows that needle tips226 and needle bases 222 have been driven proximally by needle pushingelement 224 and trigger wire 228 as described in reference to FIG. 3.Needle tips 226 and needle bases 222 are deflected outwards by ramps 230and enter a radial space between sheath 216 and catcher 240. Catcher 240may employ a conically shaped distal end to help guide the needles intothis space. As shown in FIG. 7, once needle tips 226 extend proximallypast catcher 240, they may be engaged by a proximal edge 252 of catcher240 so that they are retained when needle bases 222 are withdrawndistally. Finally, FIG. 8 shows that needle bases 222 have been fullywithdrawn distally and once again have a reduced profile by conformingto shaft 232. Needle tips 226, and correspondingly suture material 250,are retained by proximal edge 252 of catcher 240. The conicalconfiguration of catcher 240 may also facilitate travel of needle tip226 in a proximal direction while resisting travel in the distaldirection.

Sheath 216 defines an outer boundary of needle travel path so thatcatcher 240, coaxially disposed inside the sheath 216, defines the innerboundary. Sheath 216 and catcher 240 may be sized and positionedrelative to each other to either define a small radial gap or to be incontact radially at one point or more. Needle tips 226 may passlongitudinally between sheath 216 and catcher 240. In one embodiment, asmall gap may exist between catcher 240 and sheath 216 and may be sizedto allow needle passage until sufficient friction retain at least aportion of the needle(s) between catcher 240 and sheath 216. Needlecapture and retention may be created by friction against catcher 240 andsheath 216 having sufficient force to disengage needle tip 226 fromneedle base 222 when needle deployment assembly 212 is retracted in thedistal direction. Alternatively, proximal edge 252 of catcher 240 may bein contact with sheath 216 so that no gap or a gap smaller than thedimension of needle tip 226 exists, but one or both the materials aresufficiently compliant to deform and allow passage of needle tip 226. Inone aspect, needle tip 226 may be wider in dimension than needle base222 to facilitate engagement with proximal edge 252. For example, theneedle tip and needle base may be 0.5 mm and 0.4 mm in outer diameterrespectively. In embodiments exhibiting a radial gap between sheath 216and catcher 240, the space may be substantially constant longitudinallyalong the device or may taper, so that it is wider near the distal endto facilitate entry of needle tip 226 and narrower towards the proximalend to provide increasing friction for retention of needle tip 226. Thefriction may be enhanced by selecting materials having the desiredproperties for catcher 240 and/or sheath 216. Similarly, the frictionmay also be increased by the mechanical design. In other embodiments,significant friction between needle tip 226 and needle base 222 may notbe required. Needle disengagement may also be facilitated by providing acurved pathway between catcher 240 and sheath 216 though which theneedles pass when moved relatively proximally.

Turning now to FIG. 9, in an embodiment, catcher 240 may include adedicated element for engaging needle tips 226 for retention, such ascatcher dish 254 positioned proximally of stabilizer interface 256. Bothcatcher dish 254 and stabilizer interface 256 may be carried by catchertube 242. The material of stabilizer interface 256 may be selected toform a rigid connection with stabilizer 214 while the material ofcatcher dish 254 may be selected to exhibit the resilience or frictionproperties described above to allow needle tip 226 to pass in theproximal direction but resist withdrawal in the distal direction. In oneaspect, catcher dish 254 may be formed from titanium alloys, such asTi6Al4V, stainless steel, or other similar materials. In one aspect,catcher dish 254 may be configured to allow needle tips 226 to penetratethe material such that sufficient engagement is created to retain needletips 226 when needle bases 222 are withdrawn. Similarly, catcher dish254 may have slits through which needle tips 226 pass when moved to theproximal position. The proximal deflection of the material around theslits when needle tips 226 pass from the distal side to the proximalside may create an interface to facilitate retention of needle tips 226.

Stabilizer interface 256 may include guides 258 or similar structuralfeatures to help guide needle tips 226 as they travel in the proximaldirection. In one aspect, catcher dish 254 may exert a light, outwardforce on sheath 216. The conical shape of catcher dish 254 may act toguide needle tip 226 through the space between sheath 216 and catcher240. Where catcher dish 254 contacts sheath 216, the material mayslightly deform inward to allow needle tip 226 penetration. When needletip 226 has completely passed proximal edge 252, catcher dish 254 mayrebound towards sheath 216 to functions as mechanical stop againstmovement in the distal direction. Accordingly, when needle deploymentassembly 212 is retracted, needle tip 226 may be detached from needlebase 222. Any gap between catcher dish 254 and sheath 216 willsubstantially close once needle base 222 is retracted. Needle tip 226carrying suture material 250 (not shown here for clarity) may then beretained proximal to catcher dish 254.

Turning now to FIG. 10, additional details regarding an embodiment ofneedle deployment assembly 212 are depicted. As shown, needle bases 222and needle tips 226 have been moved proximally and deflected radiallyoutwards. In this drawing, stabilizer 214 is shown in its unexpandedconfiguration so as not to obscure aspects related to needle deployment,however, as described below, during normal operation stabilizer 214 maybe expanded for needle deployment. Ramps 230 guide needle tips 226 andneedle bases 222 over proximal ring 260. In some embodiments, proximalring 260 may be omitted and ramps 230 alone used to deflect the needlesto the desired piercing angle. Further, needle tips 226 and needle bases222 travel through and are constrained by distal ring 262 so that theyconform to shaft 232 distally of distal ring 262. Distal ring 262 mayserve as a guide for the plurality of needles to prevent dislodging orbuckling. When the needles are deployed, the needle tips 226 and needlebases 222 extend underneath distal ring 262 and travel over proximalring 260 causing the needles to protrude out at a piercing angle. Thepiercing angle may be established by the distance between proximal ring260 and distal ring 262 and/or by their relative diameters, as well asby the angle of ramp 230.

Further details regarding one embodiment of stabilizer 214 areschematically depicted in FIG. 11. In comparison with FIG. 3, catchertube 242 has been moved distally with respect to shaft 232. As describedabove, proximal band 234 of stabilizer 214 is secured to catcher tube242 while distal band 236 is secured to shaft 232. The relative decreasein distance between proximal band 234 and distal band 236 has caused thedeflectable wings 238 to project radially outwards, expanding stabilizer214. Thus, relative movement between sheath 216 and shaft 232 maysandwich tissue 266 to be sutured between expanded stabilizer 214 andsheath 216. Deflectable wings 238 may feature hinge points 264 atdesired locations, including locations intermediate along thedeflectable wing and/or at connections to proximal band 234 and distalband 236, to help control the expanded profile of stabilizer 214. Forexample, device 200 may be inserted at an angle of approximately 45°with respect to the vessel wall having the puncture to be closed.Correspondingly, the relative plane of tissue 266 may not besubstantially perpendicular to the longitudinal axis of device 200. Byselecting appropriate hinge points 264, deflectable wings 238 may beconfigured to provide a profile that more closely tracks the anticipatedangle of tissue 266. In the embodiment shown, fore deflectable wing 238a may expand to present a relatively shallower angle with respect to thelongitudinal axis of device 200. Similarly, aft deflectable wing 238 bmay present a relatively sharper angle when expanded. As shown, theangles presented by deflectable wings 238 a and 238 b may provideenhanced support to stabilize tissue 266. In one aspect, tissue adjacentthe more acute angle of insertion of device may exhibit a greatertendency to flow downwards and become inverted. The sharper anglepresented by deflectable wing 238 b may help lift the inverted tissue.In some embodiments, a single deflectable wing corresponding todeflectable wing 238 b may be sufficient to stabilize the sandwichedtissue.

Further, FIG. 11 also shows that a shaft 232 may have distal bleed backports 269 and 270 adjacent stabilizer 214, which are in communicationwith bleed back indicator 218 on handle 202. When device 200 ispositioned at a desired location within the patient's vasculature, bloodmay enter ports 269 and/or 270, travel through a channel in shaft 232and be visible at indicator 218. As such, blood flow at indicator 218may be provide feedback regarding the relative position of device 200with respect to the patient's vessel. In one aspect, either or bothports 269 and 270 may be employed. Port 269 will continue to providebleeding indication after expansion of stabilizer 214 and thesandwiching of tissue 266 against sheath 216. In comparison, port 270may provide bleeding indication when first positioned in the vessel, butmay be blocked by tissue 266 when the sandwich is created betweenstabilizer 214 and sheath 216, thus signaling that the sandwich has beencreated.

Additional exemplary embodiments showing different suitableconfigurations of stabilizer 214 are depicted in FIGS. 12-19. Generally,FIGS. 12, 14, 16 and 18 show plan views of alternative configurations ofstabilizer 214 represented as two-dimensional (2-D) views of astabilizer that has been cut along the longitudinal axis and laid outflat, such that the joining the opposing side edges forms a cylinder.The characteristics of each deflectable wing 238 may be established bythe relative positioning of proximal, distal and intermediate hingepoints 264. The overall length of each deflectable wing 238 depends uponthe relative distance between the proximal and distal hinge points 264,while the positioning of the intermediate hinge point 264 establisheslengths of proximal and distal portions of each deflectable wing 238 andcontrols the angle formed by the proximal portion of the deflectablewing 238 with respect to the longitudinal axis of device 200. In turn,FIGS. 13, 15, 17 and 19 show the expanded configurations when positionedwithin the patient's vasculature with an insertion angle ofapproximately 45° and the relative angles formed by the deflectablewings in relation to the vessel wall of the patient. In these views, theside deflectable wings are not shown for the sake of clarity. Althoughembodiments are discussed in the context of four deflectable wings 238,other configurations employing any suitable number of wings may beemployed as desired.

With regard to FIGS. 12 and 13, a first exemplary configuration is shownfor stabilizer 214 a. In this embodiment as depicted in FIG. 12, foredeflectable wing 238 a has substantially equal proximal and distalportions. Aft deflectable wing 238 b has a longer overall length and arelatively shorter proximal portion to establish a relatively sharpangle with respect to the longitudinal axis. Side deflectable wings 238c have equivalent overall lengths as fore deflectable wing 238 a andrelatively longer proximal portions. As shown in the corresponding FIG.13, the proximal portion of fore deflectable wing 238 a exhibits anangle substantially similar to vessel wall 268 while the proximalportion of aft deflectable wing 238 b forms a sharper angle. Aftdeflectable wing 238 b is also positioned relatively more proximal asestablished by the proximal hinge point 264.

Next, FIGS. 14 and 15 illustrate a second exemplary configuration in thecontext of stabilizer 214 b. Here, FIG. 14 depicts fore deflectable wing238 a and aft deflectable wing 238 b as having substantially equallengths, with the proximal portion of fore deflectable wing 238 asimilar in length to the distal portion of aft deflectable wing 238 b togenerate opposing symmetry. As shown in the corresponding FIG. 15, theproximal portion of fore deflectable wing 238 a exhibits a relativelyshallow angle with the longitudinal axis and a relatively perpendicularrelationship to the proximal portion of aft deflectable wing 238 b.

The third exemplary embodiment shown in FIGS. 16 and 17 includesstabilizer 214 c. As depicted in FIG. 16, fore deflectable wing 238 aand aft deflectable wing 238 b have similar overall lengths and similarproportions of proximal and distal portions. Side deflectable wings 238c have relatively shorter overall lengths with relatively longerproximal portions. Accordingly, FIG. 17 shows that both the proximalportion of fore deflectable wing 238 a and the proximal portion of aftdeflectable wing 238 b exhibit a relatively sharp angle with respect tothe longitudinal axis.

With regard to FIGS. 18 and 19, a fourth exemplary configuration isshown for stabilizer 214 d. As depicted in FIG. 18, fore deflectablewing 238 a has substantially equal proximal and distal portions. Aftdeflectable wing 238 b has a longer overall length and a relativelyshorter proximal portion to establish a relatively sharp angle withrespect to the longitudinal axis. In comparison with stabilizer 214 a,fore deflectable wing 238 b is positioned relatively more proximal. Sidedeflectable wings 238 c have equivalent overall lengths as foredeflectable wing 238 a and relatively longer proximal portions. As shownin the corresponding FIG. 19, the proximal portion of fore deflectablewing 238 a exhibits an angle substantially similar to vessel wall 268while the proximal portion of aft deflectable wing 238 b forms a sharperangle.

From the above, it will be appreciated that employing stabilizer designshaving asymmetrical deflectable wings provide a number of benefits. Byadjusting length, position and hinge points, stabilizer 214 may beconfigured to conform more closely to the anatomy of the targeted vesselwall adjacent the puncture being closed. Interaction between thedeflectable wings, and in particular, the aft deflectable wing 238 b,and sheath 216 may help lift inverted tissue. By providing positiveinteraction with tissue 266 through both stabilizer 214 and sheath 216may operate to anchor device 200 to vessel wall 268 and provide tactilefeedback about correct positioning. Further, by maintaining a distanceto needle tips 226 prior to penetration, deflectable wings 238 may allowneedle tips 226 and needle bases 222 to be deployed into a correctpiercing angle before intersecting the sandwiched tissue. Theconfiguration of stabilizer 214 may also be selected to minimize sharpedges and openings to improve smoothness and reduce damage to the vesselwall. Similarly, side deflectable wings 238 c may be configured tominimize impact with the vessel but provide structural integrity to theexpanded stabilizer.

As described above, the operations of stabilizer 214 and sheath 216 tosandwich tissue followed by the delivery of suture material 250 vianeedle tips 226 by movement of needle deployment assembly 214 andcapture of the needle tips 226 with catcher 240 may involve the relativemovement between coaxial elements of this disclosure, such as triggerwire 228, shaft 232, catcher tube 242 and/or sheath 216. For example,stabilizer 214 may be expanded by moving catcher tube 242 distallyrelative to shaft 232 to compress proximal band 234 and distal band 236together. In another aspect, tissue 266 may be sandwiched by movingsheath 216 and expanded stabilizer 214 together, such as through distalmovement of sheath 216 relative to shaft 232. In yet another aspect,needle tips 226 and needle bases 222 may be deflected into a piercingangle and driven proximally through sandwiched tissue 266 by therelative proximal movement of trigger wire 228 with respect to shaft232. Following capture of needle tips 226, needle bases 222 may bereturned to their insertion profile by the relative distal movement oftrigger wire 228 with respect to shaft 232. Additionally, stabilizer 214may be returned to its unexpanded insertion profile by the relativeproximal movement of catcher tube 242 with respect to shaft 232.

Accordingly, aspects of this disclosure include the use of handle 202 toeffect the desired relative movements of the noted coaxial elements inorder to perform the associated operations. Notably, embodiments includethe use of handle 202 to coordinate multiple movements of the coaxialelements to perform one or more of the operations discussed above withrespect to FIG. 1, including by actuating slider 204 and/or plunger 206.To help illustrate these techniques, FIGS. 20-27 schematically showdetails of handle 202 and associated components linked to slider 204 andplunger 206 and their relative movements when actuated.

Starting with FIG. 20, a side view of handle 202 is shown with slider204 in its most proximal position which corresponds to stabilizer beingin its unexpanded configuration for delivery. Slider 204 is directlycoupled to sheath 216, such that distal motion of slider 204 istranslated to distal motion of sheath 216. Slider 204 is also linked tostabilizer follower 272 by pin 278, such that distal motion of slider204 pivots stabilizer follower 272 on axle 276. Pin 278 is secured tocatcher tube 242 and is captured by a slot in stabilizer follower 272,so that catcher tube 242 is also moved distally by slider 204.Stabilizer control 280 is biased upwards towards slider 204, having aposition dictated by slider profile 282. Trigger safe 284 is also biasedupwards and constrained by slider profile 282. Shaft 232 extendscoaxially within sheath 216 and catcher tube 242 and is secured by base286 to handle 202. Trigger wire 228 is coupled to trigger rack 288, suchthat proximal motion of trigger rack 288 withdraws trigger wire 228coaxially within shaft 232. In this configuration, trigger safe 284locks trigger rack 288 in position to prevent movement of trigger wire228 until the tissue has been sandwiched.

Once device 200 has been positioned at a desired location within thepatient's vasculature, such as through use of bleed back indicator 218as discussed above, the operator may expand stabilizer 214 and sandwichtissue between the expanded stabilizer and sheath 216 by actuatingslider 204. As shown in FIG. 21, as slider 204 is moved distally, sheath216 is also moved distally relative to handle 202. Simultaneously, thedistal motion of slider 204 is translated through stabilizer follower272 to move catcher tube 242 distally relative to handle 202, andcorrespondingly, relative to shaft 232. At the position indicated bythis figure, catcher tube 242 is near the end of its range of motion,such that stabilizer 214 has been expanded and further distal movementof stabilizer follower 272 will release pin 278, decoupling catcher tube242 from slider 204. Continued distal motion of slider 204 results inthe configuration shown in FIG. 22. Sheath 216 has been moved distallyalong with the continued actuation of slider 204 to sandwich tissuebetween its distal end and expanded stabilizer 214. When slider 204reaches the most distal position, slider profile 282 allows stabilizercontrol 280 to travel upwards and engage pin 278 to prevent proximalmovement of catcher tube 242. Similarly, slider profile 282 alsoreleases trigger safe 284, allowing it to travel upwards and unlocktrigger rack 288. In this upward position, trigger safe 284 also engagesthe proximal end of slider profile 282 to lock slider 204 in the distalposition. At this stage, full actuation of slider 204 has expandedstabilizer 214 and sandwiched tissue between stabilizer 214 and thedistal end of sheath 216. In some situations, it may be desirable todiscontinue the operation before deploying the needles and suturematerial. For example, the operator may encounter calcified tissue orsome other condition that contraindicate suture delivery. Releasetrigger 220, shown in FIG. 2, may be coupled to trigger safe 284 toallow the operator to manually return trigger safe 284 to its downwardposition that relocks trigger rack 288 and unlocks slider 204, so thatthe operator may move slider 204 proximally and reverse the operationsdescribed above, releasing the sandwiched tissue and causing stabilizer214 to assume its unexpanded configuration.

After sandwiching the tissue between stabilizer 214 and sheath 216 byactuation of slider 204, plunger 206 may be actuated to deploy needletips 226 and needle bases 222 so that they penetrate the sandwichedtissue and are captured by catcher 240 and sheath 216. FIG. 23schematically depicts a top view of handle 202 with plunger 206 in itsmost proximal position. Plunger 206 is directly coupled to plunger rack290 and pinion 292 engages plunger rack 290 and trigger rack 288 for afirst range of travel from the most proximal position of plunger 206 toan intermediate position. As described above, slider 204 has beenadvanced to its most distal position and trigger safe 284 is allowed totravel upwards by slider profile 282, unlocking trigger rack 288.Correspondingly, actuation of plunger 206 distally through the firstrange of travel rotates pinion 292 to withdraw trigger rack 288 in aproximal direction. Since trigger rack 288 is coupled to trigger wire228, actuation of plunger 206 through the first range of travel alsomoves needle pushing element 224 proximally, causing needle bases 222and needle tips 226 to first deflect outward from the insertion profileshown in FIG. 5 to a piercing angle to penetrate the sandwiched tissuebefore needle tips 226 travel between catcher 240 and sheath 216 forcapture as shown in FIG. 7.

At the end of the first range of travel of plunger 206, pinion 292disengages from plunger rack 290 as shown in FIG. 24. At the same point,the distal end of plunger rack 290 directly engages the proximal end oftrigger rack 288 so that continued distal motion of plunger 206 througha second range of travel now pushes trigger rack 288 andcorrespondingly, trigger wire 228, distally to return needle pushingelement 224 to its original position. In turn, this motion withdrawsneedle bases 222 to their insertion profile in which they conform toshaft 232. The most proximal position of plunger 206 of second range oftravel is shown in FIG. 25. As can be seen, actuation of plunger 206through the second range of travel has reversed the direction of triggerrack 288, moving it relatively distal of the position shown in FIG. 24an amount sufficient to return needle deployment assembly 212 to itsoriginal position.

The configuration of handle 202 resulting from actuation of plunger 206to a position just prior to its full distal position is shownschematically in the side view of FIG. 26. Engagement between plungerrack 290 and trigger rack 288 has moved trigger rack distally so thatthe distal end engages reset link 294 which is biased in the proximaldirection. The full distal configuration of handle 202 is shown in FIG.27. The additional distal movement of trigger rack 288 has urged resetlink 294 distally, engaging and moving stabilizer controller 272 to itsdownward position. In turn this frees pin 278, allowing catcher tube 242to move proximally to its starting position. Catcher tube 242 may bebiased in the proximal direction by spring 296. Further, the material ofstabilizer 214 may have an elastic property having a tendency for it toreturn to its unexpanded configuration. For example, stabilizer may beformed from a nickel-titanium alloy such as Nitinol® having superelastic and shape memory characteristics. Accordingly, movement ofstabilizer controller 272 to its downward position allows catcher tube242 to move proximally and stabilizer 214 to assume its insertionprofile.

Following actuation of slider 204 and plunger 206 as described above,stabilizer 214 may be returned to its unexpanded configuration andneedle deployment assembly 212 may assume it insertion profile as shownin FIG. 28. Further, needle tips 226 have been captured by catcher dish254 and sheath 216, leaving loops of suture material 250 threadedthrough tissue 266. At this stage, device 200 may be withdrawn. Excesssuture material 250 may be stored in handle 202 as shown in FIG. 29,allowing device 200 to be withdrawn and suture material 250 to spoolout, reducing tension to minimize tearing of tissue 266.

As described above, the devices of this disclosure may be used to closeand facilitate repair of openings created during intravascularprocedures. For example, the Seldinger technique is a known procedurefor accessing the femoral artery and suture delivery device 100 may beused to close the opening created in the artery. More generally, thedevices of this disclosure may be used for delivery of sutures forclosing various sizes of vascular access site, and reducing the time tohemostasis and time to ambulation of patients who have undergonecatheterization procedures using sheaths in the range of 5F-24F. Stillmore generally, this disclosure is applicable to any clinical procedureinvolving closure of incisions or orifices of soft tissues and organs.For example, suture delivery device 200 or an embodiment suitablyadapted may be used for closure of soft tissue opening or tear insurgical or interventional procedures such as gastrointestinalperforation, perforated ulcer, closure of trocar incision associatedwith minimally invasive or natural orifice transluminal endoscopicsurgery, closure of patent foramen ovale (PFO), spinal annular repair,and other procedures that may benefit from suturing.

Although the first actuator is described above in the context of slider204, it will be appreciated that any suitable mechanical means such as abutton, a lever, a slider, a trigger, a plunger, a rotator, a crank orother feasible actuator that the operator can use to activate theassociated device mechanism of pressing distal device component(s)inside blood vessel and proximal device component(s) outside of bloodvessel against vessel wall, thereby sandwich the vessel wall in betweenthe device components. Similarly, although the second actuator isdescribed in the context of plunger 206, any suitable mechanical meanssuch as a button, a lever, a slider, a trigger, a plunger, a rotator, acrank or other feasible actuator that allow the user to activate theassociated device mechanism of moving needle(s) carrying suture topenetrate from one side of vessel wall to the other side (e.g., insidevessel wall to outside vessel wall) until needle(s) with suture arecaptured or retained by proximal device components positioned outsidevessel wall. In some embodiments, needle(s) may have parts that can bedetached from each other. The needle capture may involve disengaging ordetaching needle tip from the needle body or base whereby the needle tipwith suture is retained by the proximal device components outsidevessel. As noted, the second actuator may have first and second rangesof travel corresponding to relative proximal and distal motion of theneedles. Accordingly, a rotational link may provide the desired rangesof travel such as through a first 180° and a second 180°.

A device may have a needle deployment assembly comprising a needlepushing element, such as needle pushing element 224 carrying needle(s)attached to suture material 250 and connected to trigger wire 228.Trigger wire 228 moves needle pushing element 224 proximally until theneedle(s) penetrates vessel wall and captured by proximal components(e.g., catcher 240 and sheath 216) outside vessel wall. The needle(s)may have parts that can detach from each other. For example, a needlebody or base 222 may be held by the needle pushing element while theneedle tip 226 can be detached when force is applied. The needle tip(s)with suture may be retained by capture elements outside vessel wall,such as catcher 240 and/or catcher dish 254, and detached from theneedle base held by needle pushing element. The needle pushing elementcarrying needle base are returned to the original distal position on thedevice. Alternatively, needle(s) with suture may be retained anddetached from the needle pushing element. The needle pushing element isreturned to the original distal position on the device.

The detachment of needle tip(s) from needle base can occur prior to orsimultaneously as needle pushing element is retracted. Alternatively,separation of needle(s) from needle pushing element can occur prior toor simultaneously as needle pushing element is retracted.

The needles are deployed to penetrate tissue and in turn enter catcher.The needles may be retained in the catcher by friction. Friction may beprovided by various designs, components, and materials. The catcher maybe stationary during needle firing or may move distally towards theneedle deployment member or may move proximally towards handle. A sheathmay be used to guide needle movement (or define the needle movementboundary) along the device longitudinally towards proximal end. Forexample, friction capture of needle may be created by variable spacebetween sheath and catcher. Space between sheath and catcher may bewider at needle entry and narrower at needle capture. Alternatively,space between sheath and catcher may be wider for needle entry andnarrower for needle capture. In another example, the needle may becaptured due to friction of interaction with material of the catcher orsheath while the space between sheath and catcher does not changelongitudinally.

The needles may be captured in the catcher passively or actively. In thepassive embodiment, there is no component movement or one componentmovement. The variable space between the sheath and the catcher may be afixed gradient. In addition, the space between sheath and catcher may bewider at distal end and narrower at proximal end. Thus, in oneembodiment, the sheath and catcher remain stationary and the needlesenter into space defined by sheath and the catcher. In other words, theneedles move distally and are retained by the narrowing space betweensheath and the catcher. In another embodiment of the passive method, thesheath moves distally to define space for receiving the needles. Theneedles enter into the space defined by the sheath and the catcher andare bound/guided by the sheath inner-wall. The needles move distally andare retained by the narrowing space between the sheath and catcher. Thesheath retracts proximally while the catcher remains stationary.

In the active embodiment, the space between the sheath and catcher maybe a dynamic gradient. Relative motion between the sheath and catchermay change during needle movement proximally to create narrowing ofinter-space between the sheath and catcher to capture and retain theneedles. The sheath and catcher may move relative to each other tocreate more space for needle entry into inter-space. The sheath andreceiver may move relative to each other to reduce the inter-space andcapture the needles. In one embodiment, the space between the sheath andcatcher is opened up while the sheath moves distally to receive theneedles. The space between the sheath and catcher/receiver may bereduced by retracting the sheath proximally while the catcher movesdistally, or by retracting the sheath proximally while the catcherremains stationary. In another embodiment, the sheath is positionedagainst soft tissue. The space between the sheath and catcher may bereduced to receive the needles by moving the catcher distally.

In another embodiment, the variable space between the sheath and catchermay include mechanical engagement to enhance capture and retention ofthe needles more securely. The sheath may move distally to define spacefor receiving the needles. The needles then enter the space defined bythe sheath and the catcher. The needles move distally and are retainedby the narrowing space between the sheath and catcher. The retention ofthe needles may be enhanced by mechanical compression to engage theneedles. Finally, the sheath is retracted proximally while catcherremains stationary. On skilled in the art would recognize that othermethods of ensuring needle capture and retention beyond those describedherein may be implemented.

Soft tissue stabilizer 214 is used to provide stabilization between softtissue and device prior to suture deployment, minimize user effect ondevice during procedures. Soft tissue stabilizer has a firstconfiguration, (closed or low profile state) to facilitate deviceinsertion and second configuration (deployed or expanded state) toenable tissue stabilization. Soft tissue stabilizer has potentialvariations such as footing, loop, hook, anchor, asymmetric deflectablewings or deflectable wings and can be made of flexible or elastic metalsuch as metal, nitinol or polymers.

In one embodiment, the stabilizer may be omitted to allow needledeployment and suture delivery to be performed using a single actuator.For example, FIG. 30 is a schematic overview of a suture deliveringdevice 300 including handle 302 and an actuator configured as plunger304. The elongated distal portion of device 300 includes catheter 306for deployment within a patient's vessel. Guidewire exchange port 308may be used to facilitate advancement of catheter 306 over a guidewirealready positioned with in the patient's vasculature using knowntechniques. Proximal to catheter 306 is needle deployment assembly 310.Plunger 304 may be coupled to a trigger wire (not shown in thisdrawing), so that proximal movement of plunger 304 results in acorresponding proximal movement of the trigger wire. The coupling mayinvolve direct one to one movement, or may feature rack and pinionengagement or other similar mechanisms to provide a desired degree ofmechanical advantage. As will be appreciated, this may include causing afirst amount of travel of plunger 304 to result in a greater amount oftravel of the trigger wire or causing a first amount of force applied toplunger 304 to result in a greater amount of force being applied to thetrigger wire. Although described in the context of this embodiment asplunger 304, any of the actuator mechanisms described above, or anyother suitable mechanism, may be employed. Needle deployment assembly310 may be carried by a distal portion of shaft 312 as detailed below,with sheath 314 coaxially disposed over shaft 312. As shown, device 300may include a bleed back indicator 316 on handle 302 which is incommunication with a port positioned adjacent needle deployment assembly310 to provide visual feedback in the form of blood flow when needledeployment assembly 310 is positioned within the patient's vessel.

Further details regarding this embodiment are depicted in FIG. 31, whichschematically shows needle deployment assembly 310, including aplurality of needle bases 318 projecting proximally from needle pushingelement 320, with each needle having a detachable needle tip 322. Suturematerial may be threaded through or otherwise secured to an aperture inneedle tip 322 (not shown in the figure for the sake of clarity).Trigger wire 324 is secured to needle pushing element 320 and extendsproximally to handle 302 for actuation by plunger 304. For delivery,needle bases 318 and tips 322 are positioned distally of correspondingramps 326 formed in shaft 312. Trigger wire 324 is slidably disposedcoaxially within shaft 312 so that relative proximal movement of triggerwire 324 causes needle bases 318 and tips 322 to be deflected radiallyoutward to a piercing angle by ramps 326. Other suitable configurationsmay be employed to provide the outward deflection as a result ofrelative proximal movement of the needles caused by trigger wire 324,including, for example, the proximal and distal rings described above.Any suitable number of needles may be employed, such as two needle base318 and needle tip 322 sets as shown, or more. Catcher 328 is coaxiallydisposed within sheath 316, so that at least needle tips 322 may beengaged by one or both of catcher 328 and sheath 316 following relativeproximal movement in any of the manners described herein.

Described herein are certain exemplary embodiments. However, one skilledin the art that pertains to the present embodiments will understand thatthe principles of this disclosure can be extended easily withappropriate modifications to other applications.

What is claimed is:
 1. A suture delivery device for suturing an openingon tissue comprising: an elongated deployment shaft; a needle deploymentassembly carried by the shaft, including a plurality of needles carryingsuture material configured to have an insertion profile at a distalposition and to deflect radially outwards to a piercing angle when movedproximally relative to the shaft; and a catcher disposed over the shaftconfigured to retain at least a portion of each of the plurality ofneedles carrying the suture material when the plurality of needles arepassed through the tissue to be sutured to a proximal position thatengages the catcher.
 2. The suture delivery device of claim 1, whereinthe catcher is made of resilient material.
 3. The suture delivery deviceof claim 1, wherein the catcher is expandable.
 4. The suture deliverydevice of claim 1, wherein each of the plurality of needles comprises aneedle base and a detachable needle tip that carries the suturematerial, such that each needle tip engages the catcher when theplurality of needles are moved to the proximal position and the catcherretains each needle tip when each of the needle bases are returned tothe distal position.
 5. The suture delivery device of claim 4, wherein adimension of the needle tip is different from a dimension of the needlebase.
 6. The suture delivery device of claim 4, wherein each needle baseand corresponding needle tip is configured to have a retention force tokeep the needle tips in position on the needle bases until movedproximally into engagement with the catcher.
 7. The suture deliverydevice of claim 6, wherein the retention force depends at least in parton a surface treatment.
 8. The suture delivery device of claim 7,wherein the surface treatment is a layer of nitinol oxide.
 9. The suturedelivery device of claim 1, further comprising a sheath coaxiallydisposed over the catcher, wherein a distal end of the sheath cooperateswith the catcher to engage the needles when in the proximal position.10. The suture delivery device of claim 1, further comprising a handleat a proximal end of the shaft, wherein the handle has an actuatorconfigured to move the needles proximally and distally relative to theshaft.
 11. A method for delivering a suture comprising: providing anelongated deployment shaft, a needle deployment assembly carried by theshaft, including a plurality of needles carrying suture material and acatcher coaxially disposed over the shaft; advancing the elongateddeployment shaft to a desired position in a body; deflecting theplurality of needles radially outwards to a piercing angle from aninsertion profile at a distal position with proximal movement relativeto the shaft; engaging the catcher with the plurality of needles whenmoved to a proximal position by passing through the tissue to besutured; retaining at least a portion of each of the plurality ofneedles carrying the suture material with the catcher; and returning aportion of each of the plurality of needles not retained by the needlesto the insertion profile at the distal position.
 12. The method of claim11, wherein deflecting the plurality of needles radially outward,engaging the catcher with the plurality of needles and returning aportion of each of the plurality of needles not retained by the catcherto the distal position is performed by operating an actuator at aproximal end of the elongated deployment shaft.
 13. The method claim 12,wherein each of the plurality of needles comprises a needle base and adetachable needle tip that carries the suture material, such that eachneedle tip engages the catcher when the plurality of needles are movedto the proximal position and the catcher retains each needle tip wheneach of the needle bases are returned to the distal position.
 14. Themethod of claim 13, wherein each needle base and corresponding needletip is configured to have a retention force to keep the needle tips inposition on the needle bases until moved proximally into engagement withthe catcher.
 15. The method of claim 14, wherein the retention forcedepends at least in part on a surface treatment.
 16. The method of claim11, wherein a sheath coaxially disposed over the catcher includes adistal end that cooperates with the catcher to engage the needles whenin the proximal position.
 17. The method of claim 11, further actuatinga handle at a proximal end of the shaft to move the needles proximallyand distally relative to the shaft.